Efficacy of PENNSAID® for Pain Management in the Emergency Department

• Status: Withdrawn
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac under double blind conditions using a growth curve approach to pain measurement. The investigators will test the hypothesis that PENNSAID will provide more rapid pain relief than oral diclofenac during the ED visit. The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the emergency department (ED) visit.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah; Virgil Davis
• Collaborator: Medtronic - MITG
• Treatments: Diclofenac; Diclofenac hydroxyethylpyrrolidine

Criteria

Inclusion:

-We will include ED patients presenting with an acutely painful ankle sprain for which NSAIDs constitute standard of care pain management.

The following will be excluded:

• Those with lacerations, bites, burns

• any head trauma

• pregnant

• anyone with a pre-existing chronic pain condition

• inflammatory intestinal disorders such as Crohn's disease or ulcerative colitis

• anyone regularly using another NSAID or anti-coagulation medication

• anyone who has experienced asthma after NSAID use

• compromised cognitive abilities

• a significant co-morbidity that will compromise participation

• had joint replacements

• known hypersensitivity to diclofenac or allergic responses to NSAIDs as a class

• active stomach and/or duodenal ulceration or gastrointestinal bleeding

• anyone admitted with severe active bleeding

• recent heart surgery

• severe liver or renal insufficiency

• prisoner

• mentally disabled patients

• wards of the state

• cognitive or decisional impairment